Neurologix Presents New Confirmatory Results for Phase 2 Study of NLX-P101 in Parkinson’s Disease to Recombinant DNA Advisory Committee
08 Jun 2011
Gene Therapy
FORT LEE, N.J., June 8, 2011 /PRNewswire/ — Neurologix, Inc.
(OTCBB: NRGX) announced today several new results from the
Company’s successful Phase 2 clinical trial for its novel,
investigational gene therapy NLX-P101 for the treatment of
Parkinson’s disease (PD) as part of a comprehensive presentation of
study findings to the National Institutes of Health (NIH)
Recombinant DNA Advisory Committee (RAC). Recently completed
analysis of new data showed patients treated with NLX-P101 had
significantly increased “ON” times, or periods in which the
symptoms of PD are best controlled, compared to sham subjects over
the course of 12 months following treatment (p<0.05; ANOVA).
Significant reductions in complications due to medical therapy were
also seen following treatment with NLX-P101. These new findings,
which demonstrate patients treated with NLX-P101 maintained
statistically significant, positive, long-term improvements at 12
months, were included in today’s presentation of results from the
landmark Phase 2 trial by Matthew J. During, M.D., D.Sc., one of
the scientific co-founders of Neurologix.
Patients with moderate to advanced PD often suffer from reduced
effectiveness of medication, including less time spent each day in
the better or “ON” state. The new findings presented today of the
NLX-P101 Phase 2 study demonstrated that treatment with the novel
gene therapy resulted in an average daily increase of 2.5 hours of
“ON” time at 3 months (p<0.01 relative to baseline; t-test) and
this increase was sustained at 2.1 hours of greater “ON” time at 12
months (p<0.01 relative to baseline; t-test). There was no
significant increase in “ON” time in sham patients at any time
point.
There was also a significant reduction in complications of
medication in the NLX-P101 group at 6 and 12 months following
treatment (p<0.01 and p<0.05, respectively; t-test) as
measured by Part 4 of the Unified Parkinson’s Disease Rating Scale
(UPDRS), with no s
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